FDA continues to scrutinize synthetic nicotine products – POLITICO

With Megan R. Wilson

It’s Thursday. welcome to Impulse. I’m Katherine Ellen Foley, Staff Reporter for the FDA, and aside from all the regulatory news, I’m thrilled to report that my favorite canadian pop princess been very busy lately. Send tips, comments and your favorite summer jams to [email protected].

FDA ORDERS 88,000 PRODUCTS WITH SYNTHETIC NICOTINE OFF-MARKET – The FDA’s chief tobacco regulator said Wednesday that the agency has sent “refusal to accept” letters to manufacturers of more than 88,000 products containing lab-made nicotine, Your Host reports.

This latest update from Center for Tobacco Products Director Brian King sheds some more light on the agency’s progress in regulating products containing nicotine from sources other than tobacco, which the FDA has cleared. to regulate this spring. Previously, the agency could only regulate products containing nicotine derived from the tobacco plant, creating a regulatory loophole that allowed some e-cigarette makers to avoid being taken off the market.

A regulatory gray zone: King’s update said letters to manufacturers whose claims did not meet “indicate that it is illegal to sell or distribute in the U.S. market any new tobacco product that has not received pre-marketing authorisation”. The agency has not blessed any synthetic nicotine products with marketing orders.

The law authorizing the FDA to regulate products stated that as of July 13, all unauthorized synthetic nicotine products were illegal. In any event.

But, the agency also noted that it will continue to evaluate more than 350 applications of synthetic nicotine products that appear to have adequate materials. While these products — most of which are vapes — aren’t technically cleared for sale, it’s unclear whether the FDA will pull them from the market while it evaluates the materials required. The agency has used its enforcement discretion on e-cigarettes containing tobacco-derived nicotine, allowing them to remain on shelves while it continues to weigh their applications.

A stacked process: Jonathan Foulds, a professor of public health sciences specializing in tobacco addiction at Penn State College of Medicine, told Pulse that among the makers of synthetic nicotine e-cigarettes, some were absolutely bad actors who used tobacco. regulatory loophole to stay on the market when their products appealed to teenagers.

But other manufacturers probably never had a chance, given their tight schedule to gather the materials. “I would be surprised if any of them were allowed, to be honest,” he told Pulse. “It’s a big job that requires a lot of information, including proper research that takes time. You can’t do it in two months. He pointed out that even makers of vapes containing tobacco-derived nicotine struggled to meet the FDA’s evidentiary requirements, even though they had years to apply for marketing orders.

“I would be ok if all were taken off the market [while the agency conducts its review]but they deserved enough time to put together a candidacy,” he added.

DEVICE STERILIZATION FACILITIES PUT 23 COMMUNITIES TO HIGH CANCER RISKA new report from the Environmental Protection Agency shows that 23 U.S. communities near facilities that sterilize medical devices face significantly higher cancer risks than the agency’s maximum acceptable threshold, report Annie Snider and David Lim. from POLITICO.

The risk stems from high levels of ethylene oxide, a carcinogenic gas, used to sterilize about half of all medical devices in the country, including most surgical trays and IV tubing. Residents of Fajardo, Puerto Rico are at high risk from emissions of the carcinogenic chemical ethylene oxide which, over their lifetime, puts them at a 60 times higher risk of developing cancer than the upper safety threshold of the EPA. Generally, historically underserved populations are more likely to live near sterilization facilities.

Ethylene oxide is the only way to sterilize some devices. Jeff Shuren, the FDA’s lead medical device regulator, said in a statement that while the agency is concerned about ethylene oxide, “we are also concerned about the potential impact of medical device shortages. sterilized as a result of disruptions in commercial sterilization facilities”. operations. »

The EPA report comes as the agency prepares to release updated airline regulations for the sterilization industry; its earlier directives, on which Wednesday’s report is based, date back more than two decades. For now, the EPA will hold a virtual public meeting on August 10 at 8 p.m. to raise awareness of the national scope of the risks associated with ethylene oxide, and it will organize local meetings for these communities. The agency also plans to hold local meetings in communities most at risk.

KANSAS LANDSLIDE FUELS THE ABORTION RIGHTS MOVEMENT’S NEXT FIGHTS — Kansas’ landslide defeat on Tuesday of a ballot measure that would have removed abortion rights protections from the state’s constitution gives Democrats hope they can use ballot measures already slated for this fall in Michigan, Kentucky and other states, our Alice Miranda Ollstein reports from the field.

The surprise 20-point margin in one of the nation’s most conservative states highlighted the gap between what most voters want and what a number of Republican candidates and lawmakers are pushing. Voter turnout on Tuesday approached general presidential election levels in some areas, giving progressives an injection of hope that their message can resonate beyond cities and suburbs this fall.

“Poll initiatives are an extremely powerful tool when there is a mismatch between the popularity of an issue and what is embraced by politicians. And every poll in the country shows this disconnect when it comes to abortion rights,” said Kelly Hall, executive director of the Fairness Project, a national group that advocates ballot measures as a strategy to circumvent legislatures and governors. GOP states on everything. from Medicaid expansion to transgender rights and abortion.

“It really is the next frontier and defenders are already starting to think about pathways for 2023 and 2024,” she added.

FLORIDA GOVERNMENT RECLAIMS CONCERN ABOUT MONKEYPOX IS OVERHANGEDGOP Governor Ron DeSantis on Wednesday tried to play down anxiety over monkeypox, saying politicians and the media had exaggerated the severity of the disease and equated it with fears surrounding Covid-19, reports POLITICO’s Arek Sarkissian. The state has the fifth-highest case count in the nation, with 525 cases as of Tuesday.

“I’m so sick of politicians, and we’ve seen it with Covid, trying to instill fear in the population,” he said at a news conference near Orlando. “We are not scary.”

During the same press conference, DeSantis’ surgeon general, Joseph Ladapo, said Florida has a sufficient number of monkeypox vaccines. A Department of Health and Human Services database shows the state was allocated 36,383 doses of the Jynneos vaccine, which is licensed to prevent monkeypox and smallpox, last week.

MODERN PLANS TO BRING ITS MONKEYPOX VACCINE TO CLINICAL TRIALS — Moderna executives told investors on Wednesday that the biotech company continues to explore whether to move forward with development of a monkeypox vaccine and plans to discuss with global regulators, reports David. “Given recent public health announcements and growing concerns about vaccine supply availability, we have begun to review what it would take for us to use our platform to deliver a monkeypox vaccine,” said Moderna Chairman Stephen Hoge during an earnings call.

Illy Jaffer will join the Blue Cross Blue Shield Association next week as Director General of Federal Government Relations. She just served in the American Cancer Society Cancer Action Networkthe lobby shop.

POLITICO’s Eugene Daniels sat down with activist and filmmaker David France to talk about the parallels between the HIV crisis and the monkeypox epidemic in the United States.

A Grid analysis of LinkedIn profile data led by Dan Vergano sheds light on the full extent of the FDA’s revolving door problem.

The Red Cross has begun screening blood donations and weapons for evidence of monkeypox, reports Megan Molteni for STAT.

Music festivals are just starting to see the value of naloxone but remain wary of fentanyl test strips that could help attendees avoid overdoses in the first place, reports Blake Farmer for Nashville Public Radio and Kaiser Health News.

CORRECTION: A previous version of this newsletter incorrectly indicated when the Pennsylvania ballot measure might occur.

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